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Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Pediatric Tethered Cord Syndrome Surgery (ESPB)

B

Bursa Yuksek Ihtisas Training and Research Hospital

Status

Completed

Conditions

Erector Spina Plan Block

Treatments

Device: UNDER ULTRASOUND GUİDANCE ESPB BLOCK
Procedure: PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE

Study type

Interventional

Funder types

Other

Identifiers

NCT07404995
2024-KAEK-13

Details and patient eligibility

About

Tethered Cord Syndrome is a developmental anomaly of neuroaxis characterized by stretching of the spinal cord and is diagnosed in the pediatric age group. Surgical release of the tight and tethered filum terminale is performed. Intraoperative neurophysiological monitoring (IONM) is used to preserve functional nerve tissue and prevent postoperative neurological deficits. Total intravenous anesthesia (TIVA-TCI) with propofol and remifentanil is used as the anesthesia method to ensure accurate measurements. Postoperative pain is acute pain caused by surgical trauma and signal transmission in afferent neurons. Pediatric postoperative pain is associated with adverse behaviors, prolonged hospital stay, and impaired functional recovery. Although good progress has been made in pain management, ineffective postoperative pain management in children remains a global problem. Regional anesthesia is increasingly used in pediatric patients to provide postoperative analgesia and support intraoperative anesthesia. Ultrasound-guided erector spinae plane block (ESPB) is a new approach. First introduced in 2016 by Forero et al., ESPB is a novel regional anesthesia technique that blocks the branches of spinal nerves by injecting a local anesthetic into the fascial plane between the erector spinae muscle and the transverse process. The aim of our study was to reduce intraoperative anesthetic drug consumption, postoperative pain levels in the first 24 hours, the need for analgesics, and unwanted side effects associated with analgesics by applying bilateral ESPB in pediatric patients operated on for Tethered Cord Syndrome. Our hypothesis in this study is that bilateral ESPB reduces intraoperative anesthetic drug consumption and the need for postoperative analgesia in pediatric patients operated on for Tethered Cord Syndrome.

Full description

Ultrasound-guided erector spinae plane block (ESPB) that aims for the ventral and dorsal rami of the spinal nerves was recently introduced in spine surgery to treat postoperative pain. ESPB was reported to be effective in scoliosis surgery as it reduced the need for analgesic drugs. Due to its relative technical simplicity, the main advantages postulated for the ESPB are few complications and minimal risk for spinal cord injury.

Enrollment

73 patients

Sex

All

Ages

1 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Patients whose parents have given their consent to the study

  • Patients aged 18 and under
  • Patients with ASA (American Society of Anesthesiologists) physical status I, II, and III
  • Pediatric patients who will undergo elective Tethered Cord Syndrome surgery

Exclusion Criteria:Patients whose parents did not consent to participate in the study

  • Patients with ASA physical status IV and V
  • Those using anticoagulant medications
  • Allergy to local anesthetic drugs
  • Patients with a history of gastrointestinal bleeding
  • Those with infection in the area where the block is planned

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

73 participants in 1 patient group

UNDER ULTRASOUND GUİDANCE ESPB GROUP
Experimental group
Description:
Under ultrasound guidance, bilateral erector spinae plane block will be performed on the ESPB group one level above the appropriate area for pediatric tethered cord surgery using the anesthetic drug bupivacaine.
Treatment:
Procedure: PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE
Device: UNDER ULTRASOUND GUİDANCE ESPB BLOCK

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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